Effect of patient-controlled sedation with propofol on patient satisfaction

ISRCTN	ISRCTN81377748
DOI	https://doi.org/10.1186/ISRCTN81377748
Secondary identifying numbers	00/15

Submission date: 27/03/2013
Registration date: 16/04/2013
Last edited: 16/04/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
A national survey carried out by the French Society of Anesthesia and Critical Care with INSERM showed that 15% of anesthetic acts in France were due to diagnostic procedures. Several authors have raised this issue because of the cost involved at national level. For invasive diagnostic radiology (angiography), the necessity of the presence of an anesthesiologist is highly controversial. The safety aspect is mentioned but it is questionable because accidents are rare (approximately 0.1%) in those procedures. This explains that, in many centres, an anesthesiologist can be reached in case of an incident but is not present during the whole procedure. Another justification is to improve patient comfort and satisfaction. Some patients do not want to be sedated because of the possibility of post interventional drowsiness and legal constraints related to the anesthetic action (visit 48 hours in advance, monitoring for several hours etc). This uncertainty about the desired level of sedation is reflected in a wide range of anesthesia practices, ranging from simple monitoring to deep sedation for arteriography.
Controlled sedation the patient (also called PCS) is a method derived from patient-controlled analgesia or PCA. The advantage of this technique is to control the patient's level of sedation. This study assesses how well the PCS method works.

Who can participate?
Participants aged under 70 years, with ASA physical status below 3, a scheduled cerebral angiography, and a consultation with an anesthetist at least 48 hours before the procedure.

What does the study involve?
61 patients were randomly allocated to one of two groups: receiving propofol-based PCS (n = 33, 15 mg bolus in 9 s) or placebo-based PCS (n = 28, bolus of 1.5 mL of a 20% lipid emulsion in 9 s).

What are the possible benefits and risks of participating?
Possible benefits were an improve experience of the sedation and fast recovery. Potential risks were insufficient sedation or secondary effects of propofol.

Where is the study run from?
France, Public Hospital of Marseille, neuroradiology operating room.

When is the study starting and how long is it expected to run for?
The study started in January 2000 and was expected to last 6 months.

Who is funding the study?
There was institutional funding from AP-HM, Public Hospital of Marseille, Research Department.

Who is the main contact?
Dr Axel Maurice-Szamburski
axel.maurice@ap-hm.fr

Contact information

Dr Axel Maurice-Szamburski
Scientific

264 rue St. Pierre
Marseille
13009
France

Email	axel.maurice@ap-hm.fr

Study information

Study design	Prospective double blinded randomised
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of patient-controlled sedation with propofol on patient satisfaction: a randomised study
Study objectives	The aim of this study was to evaluate the difference in patient satisfaction, assessed by a specific and validated scale, using a propofol-based PCS compared to placebo-based PCS for diagnostic cerebral angiography.
Ethics approval(s)	Ethical approval n°:00/15, Chairperson Pr. J-C Manelli, Ethical Committee: CPP Sud-Méditerranée II - Hôpital Salvator, Marseille, France.
Health condition(s) or problem(s) studied	Diagnostic cerebral angiography
Intervention	We randomly assigned 61 patients to receive propofol-based PCS (n = 33, 15 mg bolus in 9 s) or placebo-based PCS (n = 28, bolus of 1.5 mL of a 20% lipid emulsion in 9 s).
Intervention type	Other
Primary outcome measure	The main objective was to evaluate whether a propofol-based PCS would lead at least to 20% difference in patients satisfaction on the EVAN scale, which was self reported the day after the procedure.
Secondary outcome measures	Secondary objectives were to assess the quality of patient conditioning by the neuroradiologist and the anesthetist and to report possible side effect.
Overall study start date	01/01/2000
Completion date	01/07/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Age under 70 years 2. ASA physical status below 3 3. Scheduled cerebral angiography 4. Consultation with an anesthetist at least 48 hours before the procedure
Key exclusion criteria	1. Age under 18 years, 2. Emergency context 3. History of psychiatric disease 4, Long-course anxiolytic treatment 5. Counter-indication to propofol 6. Withdrawal of consent
Date of first enrolment	01/01/2000
Date of final enrolment	01/07/2000

Locations

Countries of recruitment

France

Study participating centre

264 rue St. Pierre

Marseille
13009
France

Sponsor information

Assistance Publique Hôpitaux de Marseille AP-HM (France)
Hospital/treatment centre

264 rue St.Pierre
Marseille
13005
France

Website	http://www.ap-hm.fr
"ROR"	https://ror.org/00pg5jh14

Funders

Funder type

Hospital/treatment centre

Institutional funding from AP-HM, Public Hospital of Marseille, Research Department.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2005		Yes	No
Results article	results	01/01/2013		Yes	No